Method and apparatus for passing suture

ABSTRACT

A device is disclosed that can pierce and hold tissue and then pass suture through tissue. The device can have a shuttle that can removably attach to a suture and jaws that can be rotatably opened and closed with respect to each other. A method for using the device to repeatedly pass the suture through the tissue without removing the suture or device from the target site is also disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Pat. Application No.16/147,162 filed Sep. 28, 2018, which is a continuation of U.S. Pat.Application No. 14/255,945 filed Apr. 17, 2014 (now U.S. Pat. No.10,258,322), which claims the benefit of priority to U.S. ProvisionalApplication No. 61/812,805 filed Apr. 17, 2013, the contents of each ofwhich are incorporated herein by reference in their entirety for allpurposes.

BACKGROUND 1. Field Of The Invention

The present invention relates to system, methods, and apparatus forenhancing the advancement and retention of suture through tissue.

2. Description Of Related Art

Suturing apparatus in the past have had an elongate shaft and a lowprofile distal clamping mechanism to facilitate their use throughcannulas 226 in less invasive surgery. These devices have typicallyincluded opposing jaws which clamp onto the tissue to be sutured. Theend segment of the suture is pre-positioned and secured at the distalend of one jaw member. Beyond the clamping motion, the mechanism forpassing a suture between the jaws and through the tissue incorporates abendable needle. The bendable needle advances distally within the jawmember, bringing it in contact with a segment of the suture.

The needle engages and secures the suture to carry it forward. Thisdistal advancement of the bendable needle also results in the leadingend of the needle to approach and engage a ramp 44 in the jaw member,deflecting the bendable needle in a direction toward the opposing jaw.The bending of the needle requires a high force and results in excessstrain on the needle component. Fracture and failure of the bendableneedle is a concern.

Additionally, the bendable needle is further advanced after beingdeflected in a direction extending away from the jaws, and potentiallyinto unintended anatomy. Extension of the needle in this manner is asafety concern. Even after the apparatus has completed passing thesuture through the tissue, the end segment of the suture must beretrieved by retracting the entire apparatus out of the cannula.

It would be advantageous to have an apparatus that could load and unloadsuture without the need to remove the apparatus from the surgical site.

It would be advantageous to have an apparatus that could pass (not loadand unload) suture repeatedly through tissue without the need to removethe apparatus from the surgical site. It would also be advantageous forthe suture shuttling mechanism (either needle or shuttle) to be entirelycontained within the apparatus during operation to improve accuracy ofsuture placement and improve safety of needle or shuttle position duringoperation.

SUMMARY OF THE INVENTION

A device and method for passing suture through soft tissue is disclosed.The suture passer can perform multiple passes of the suture withoutwithdrawing the suture passer from the target site, such as during arotator cuff repair procedure.

The suture passing device can be made to have no mechanical pivotinglinks. The suture passing device can have no hinges in the jawstructure. The jaw structure can open and close with hinge-less action.

The suture can be mounted on the lateral side of the jaw structure.

A shuttle for holding and moving the suture can be captured and heldwithin the jaws, for example creating a design of the device that has noloose parts capable of being separated from the device during use.

The jaws and/or the shaft or compression cover of the device can be madefrom a resilient metal such as Nitinol or any other material disclosedherein.

The device can pass suture repeatedly through tissue without the need toremove the apparatus from the surgical site or to load and unload thesuture from the device. The suture shuttling mechanism (e.g., the needleand/or the shuttle) can be partially or entirely contained within theapparatus during operation to improve accuracy of suture placement andimprove safety of needle or shuttle position during operation.

BRIEF DESCRIPTION OF THE FIGURES

FIGS. 1 a, 1 b and 1 c are perspective, top and side views,respectively, of a variation of the suture passing device.

FIGS. 2 a and 2 b are a distant and close-up view, respectively, of avariation of the shuttle in a straight configuration.

FIG. 2 c is a close-up view of the variation of the shuttle from FIGS. 2a and 2 b in a curved configuration.

FIG. 3 a is a close-up, perspective, partial see-through view of thedistal end of a variation of the suture passing device attached to alength of a suture.

FIG. 3 b is a close-up view of a portion of FIG. 3 a .

FIGS. 4 a and 4 b are close-up perspective and side views, respectively,of the distal end of a variation of the suture passing device in aclosed configuration.

FIG. 4 c is a close-up of the distal end of FIGS. 4 a and 4 b .

FIG. 4 d is a close-up perspective view of the distal end of the deviceof FIG. 4 a in a closed configuration.

FIG. 5 is a variation of cross-section A-A of FIG. 1 a with the deviceattached to a length of a suture.

FIGS. 6 a through 6 d illustrate a variation of a method of using avariation of the suture passing device to create a stitch in a piece oftissue.

FIGS. 7 a and 7 b are a side perspective view and a close-up a variationof the device with an exploded view of a shuttle, and a close-up of theproximal end of the device, respectively.

FIG. 7 c is a close-up view of the variation of the shuttle in FIG. 7 a.

FIG. 7 d is a close-up view of the distal end of the variation of thedevice shown in FIG. 7 a .

FIG. 8 a illustrates a variation of the shuttle.

FIG. 8 b illustrates a close-up view of a variation of the distal end ofthe device.

FIGS. 9 a and 10 a are side perspective and partial see-through sideperspective views, respectively, of a variety of the device in an openedconfiguration.

FIGS. 9 b and 11 a are side perspective and side cross-section views,respectively, of a variety of a method for closing the jaws of thedevice of FIG. 9 a .

FIGS. 9 c and 11 b are a close-up view and a side see-through view,respectively, of the distal end of the device in FIG. 9 b .

FIG. 10 b is a close-up partial see-through view of the distal end ofthe lower jaw of FIG. 10 a .

FIGS. 12 a through 12 c are side, top and bottom views, respectively, ofa variation of the shuttle.

FIGS. 13 a and 13 b illustrate variations of the shuttle.

FIGS. 14 a through 14 c are top end, front perspective, and bottomperspective views, respectively, of a variation of the shuttle.

FIGS. 15 a through 15 c are side perspective, bottom perspective, andside-bottom perspective views of a variation of the shuttle.

FIGS. 16 a and 16 b are top perspective and side perspective views of avariation of the shuttle.

FIG. 17 a illustrates a variation of the device with the shuttle ofFIGS. 12 a through 12 c .

FIG. 17 b illustrates a variation of the device of FIG. 17 a with apusher.

FIGS. 17 c and 17 d illustrate a variation of the device of FIG. 17 awith two pushers in different configurations.

FIGS. 18 a and 18 b are side perspective and side views, respectively,of a variation of the distal end of the device.

FIGS. 19 a and 19 b are side perspective and side views, respectively,of a variation of the distal end of the device.

FIGS. 20 a and 20 b are side perspective and side views, respectively,of a variation of the distal end of the device.

FIGS. 21 a and 21 b are side perspective and side views, respectively,of a variation of the distal end of the device.

FIGS. 22 a and 22 b illustrate a variation of the distal end and distallower jaw, respectively, of the device.

FIG. 22 c is a side view of the device of FIG. 22 a with a shuttle.

FIGS. 23 a and 23 b are a variation of the distal end of the device inopen and closed configurations, respectively with the device of FIG. 23b having a shuttle.

FIGS. 24 a through 24 c are side perspective, side and distal end views,respectively, of a variation of the device.

FIGS. 25 a through 25 f are bottom and side perspective, partialsee-through (the upper jaw is see-through), longitudinal cross-section,partial cut-away close-up, and partial cut-away views, respectively, ofthe distal end of a variation of the device with the jaws in an openedconfiguration with the shuttle and pushers in various positions, andwith the compression cover not shown in FIG. 25 f for illustrativepurposes.

FIG. 26 a is a side perspective view of a variation of the distal end ofdevice with the jaws in a closed configuration with the shuttle in theupper jaw and not engaged in the lower jaw.

FIGS. 26 b and 26 c are longitudinal cross-section and side perspectiveviews, respectively, of the device of FIG. 26 a with the shuttle in thetop and bottom jaws. FIG. 26 b does not show the pushers forillustrative purposes.

FIG. 26 d is a partial cut-away view of FIG. 26 c .

FIG. 27 is a close-up, partial cut-away view of the distal end of avariation of the device with the shuttle in the lower jaw and the upperpusher extending out of the upper jaw and partially entering the lowerjaw.

FIG. 28 is a close-up end perspective view of a variation of the devicewith the shuttle and suture of FIGS. 13 a or 13 b .

FIG. 29 is a close-up end perspective view of a variation of the devicewith the shuttle and suture of FIGS. 14 a through 14 c .

FIGS. 30 a and 30 b are right rear, and left cut-away views,respectively, of a variation of the device.

FIG. 31 is a partially cut-away and partially see-through view of theproximal end of a variation of the device.

FIGS. 32 a and 32 b are left and right perspective views of a variationof the pusher drive gears of the device.

DETAILED DESCRIPTION

FIGS. 1 a through 1 c illustrate a suture passing device 188 that can beused to pass suture 70 through soft or hard tissue 74 without removingthe device 188 or the suture 70 from the target site while creating oneor more complete stitches.

The suture passing device 188 can have an ergonomic handle 104, asliding tube actuator 6, and a distal end 2. The ergonomic handle 104can be used to control the distal end 2. The ergonomic handle 104 canhave a side knob 10. The ergonomic handle 104 can have a top knob 12.The top knob 12 and/or the side knob 10 can individually or in concert,advance and/or retract the upper 86 and/or lower pusher 76.

The sliding tube actuator 6 can have an outer compression cover 34 andan inner rod (not shown due to obstruction by the outer compressioncover 34). The inner rod can be fixedly attached to the handle 104 andthe proximal end of the jaw structure 28. The outer compression cover 34can be radially outside of the inner rod. The outer compression cover 34can be actuated by the handle 104, for example be distally andproximally translated with respect to the handle 104 when the trigger 8is squeezed or released.

FIGS. 2 a and 2 b illustrate that the device 188 can have a slidingribbon shuttle 14 or needle held within the device 188. The shuttle 14can have an elongated shuttle rail 16. The shuttle rail 16 can havenumerous slits 20 along one or both sides of the shuttle rail 16. Theslits 20 can be positioned at regular or irregular length intervalsalong the rail 16.

The shuttle 14 can have a suture holder 18 extending laterally from therail 16. The shuttle 14, for example the suture holder 18, can extendout of the lateral side slot 72 of the arm structure. The suture holder18 can extend from the left and/or right side of the device 188. Thedistal end 2 of the device 188 can be reversible so the suture holder 18can be switched from one side of the device 188 to the other side of thedevice 188. The suture holder 18 can have a generally flat, isoscelestrapezoid configuration. The suture holder 18 can have a suture holdingnotch 100. The notch 100 can have an inner hole 17 a, an outer hole 17 bcontiguous with the inner hole 17 a, and a first cleat 97 a positionedbetween the inner hole 17 a and the outer hole 17 b. The notch 100 canhave a second cleat 97 b on the side of the outer hole away from theinner hole. The notch 100 can be configured to secure to suture 70. Forexample, the suture 70 can be compressed and friction fit in the innercleat 97 a.

The suture holder 18 can have a front leading edge and a rear leadingedge. The edges can be slanted at a right or non-right angle withrespect to the longitudinal axis of the rail 16. One or both of theedges can be sharpened to be traumatic to tissue 74, for example to cutthrough soft tissue 74. The edges can cut through tissue 74, allowingthe suture holder 18 to pull the suture 70 through the tissue 74immediately behind the respective edge.

The shuttle 14 can be made from a flexible polymer, such as PEEK, aresilient metal such as Nitinol, any material disclosed herein orcombinations thereof. The shuttle 14 can be made from a molded polymer.The shuttle 14 can be pre-curved, for example to reduce resistance whengoing around curves in the tracks.

FIG. 2 c illustrates that the rail 16 can curve at the locations of theslits 20, and/or the rail 16 can be pre-curved.

FIGS. 3 a and 3 b illustrate that the suture passing device 188 cancapture or releasably attach to the suture 70 in the inner and/or outercleats 97 a and/or 97 b of the suture holder 18. The suture 70 can beloaded or held laterally of the jaw structure 28, out of plane with therotation of the jaws. The device 188 can make multiple passes of thesuture 70 through the tissue 74 without extracting or reloading thesuture passing device 188. The jaw structure 28 can resiliently deformopen at the proximal end of the jaw structure 28, having no hinge. Thejaws can be opened and/or closed with no mechanical pivots or linkagesin the jaw structure 28.

FIG. 4 a illustrates that the suture passer device 188 can have a jawstructure 28 with a top jaw 30 and a bottom jaw 38. The entire jawstructure 28 can be an integral piece of material, such as a singlemolded, cast, or cut element of Nitinol, other resilient metal orpolymer, any other material listed herein, or combinations thereof. Thejaw structure 28 can be configured to be in an opened configuration (asshown in FIG. 4 d ) when in an unbiased configuration (i.e., when noexternal forces are applied).

The jaw structure 28 can have a jaw structure longitudinal axis 42. Eachjaw can also have a respective jaw longitudinal axis along the jaw.

The inside channel of the compression cover 34 can be sized and shapedto fit over the jaw structure 28 with minimum clearance when the jawstructure 28 is in a closed configuration. When the compression cover istranslated distally 138 with respect to the jaw structure 28, as shownby arrow, the compression cover 34 can press the top and bottom jaws 38toward the jaw structure longitudinal axis 42. The jaw structure 28 canbe fully compressed into a closed configuration, as shown in FIGS. 4 athrough 4 c . In this way, when an actuation lever such as the trigger 8is actuated, the channel or compression cover 34 can advance to camclosed the jaws. The jaws can pre-pierce the tissue and establish acontinuous track for the shuttle to pass through the tissue.

The compression cover 34 can be attached to an opening ball 32positioned between the first and second jaws.

FIG. 4 b illustrates that the opening ball 32 can be rotatably orfixedly attached to a ball axle 52 passing laterally through the openingball 32. The ball axle 52 can extend out from the lateral sides of theball 32. The ball axle 52 can be slidably received by axle slots 50formed through distal arms 54 or extensions 138 of the compression cover34. When the jaw structure 28 is in a closed configuration, the ballaxle 52 can abut and interference fit against the proximal end of theaxle slot 50, for example to prevent overextension of the compressioncover 34 over the jaw structure 28. When the jaw structure 28 is in anopened configuration, the ball axle 52 can abut and interference fitagainst the distal end 2 of the axle slot 50, for example to preventoverrotation of the jaws and/or pulling the ball 32 past the ramps 44 onthe inside of the jaw structure 28.

FIG. 4 c illustrates that the bottom track 66 can distally terminate ina bottom track port 62. The top track 64 can distally terminate at a toptrack port 60. The top track port 60 can align with and be adjacent to(as shown) or in contact with the bottom track port 62 when the jawstructure 28 is in a closed configuration with the first jaw tip 46interdigitating with the second jaw tip 48. The tracks of the upper jaw78 and bottom jaw 38 can form a continuous path when the jaw structure28 is in a closed configuration. The first jaw tip 46 can interdigitatewith and be adjacent or in contact with the second jaw tip 48 when thejaw structure 28 is in a closed configuration.

FIG. 4 d illustrates that that compression cover 34 can be translatedproximally 126, as shown by arrow, with respect to the jaw structure 28.The ball axle 52 can slide to the distal end 2 of the axle slot 50. Theaxle slot 50 can then pull the ball axle 52, and therefore the openingball 32, proximally. The opening ball 32 can then press against theinside surface ramp 44 of the first jaw and/or second jaw. The first jawtip 46 and/or second jaw tip 48 can then rotate away from the opposingjaw tip. The jaw structure 28 can then be in an opened configuration, asshown.

The proximal ends of the jaws can be rigid or flexible, for example tobend around the opening of the compression cover 34 when the jaws are inan opened configuration. The entire jaws or just the proximal ends ofthe jaws can be made from Nitinol, for example with the distal ends ofthe jaws made from stainless steel.

FIG. 5 illustrates that the side slot 72 can extend laterally from oneside of the tracks. The rail 16 of the shuttle 14 can be taller than theheight of the side slot 72. The rail 16 can be too large to pass throughthe side slot 72. The suture holder 18 can extend laterally from therail 16 through the side slot 72. The suture holder 18 can hold thesuture 70 laterally spaced away from the jaw.

FIG. 6 a illustrates that the upper jaw 78 and the lower jaw 80 can beclosed, as shown by arrows, and compressed through tissue 74, such assoft tissue 74 in the rotator cuff or other joint. The upper jaw tip 206and/or the lower jaw tip 198 can pierce the tissue 74. The upper jaw tip206 and the lower jaw tip 198 can interdigitate in or adjacent to thetissue 74. The hole created by the touching or interdigitating of theupper jaw tip 206 and/or the lower jaw tip 198 can be a hole in thetissue 74 through which the shuttle 14 and/or suture 70 can pass. Thecompression cover can be pushed distally 138 to further compress thefirst jaw toward the second jaw, for example to force the jaw tips topierce the tissue 74.

The lower pusher 76 can be advanced distally, as shown by arrow, ascontrolled by the handle 104. The lower pusher 76 can force or push theshuttle 14 through the track to move distally and to carry the suture 70with the shuttle 14.

FIG. 6 b illustrates that the lower pusher 76 can continue to be pushedby the handle 104. The lower pusher 76 can push the shuttle 14 throughthe tissue 74. The front edge 22 of the suture holder 18 can cut throughthe tissue 74 and the suture holder 18 can pull the suture through thecut created in the tissue 74 by the front edge 22 and/or through thepiercing created in the tissue 74 by the tips of the jaw. The pusher andthe shuttle 14 can move along the longitudinal axis of the jaws.

The shuttle 14 can then be positioned entirely in the track of the upperjaw 78. The lower pusher 76 can then be withdrawn from the track of theupper and/or lower jaw 80, and/or the lower pusher 76 can be left inplace but the resistive force can be removed, allowing the lower pusher76 to slide freely in the tracks.

FIG. 6 c illustrates that the compression cover can then be translatedproximally 126 (e.g., by releasing or squeezing the trigger 8), as shownby arrow 83. The ball axle 52 can be pulled proximally, forcing theopening ball 32 against the inner surface of the top and/or bottom jaws38. The opening ball 32 can thus resiliently force open the top and/orbottom jaw 38. The jaws can then be unclamped (i.e., rotated open, asshown by arrows 82), and be cleared from the tissue 74.

The device 188 can then be shifted to a position where the distal end 2of the device 188 is adjacent (e.g., lateral) to where the sutureinitially passed through the tissue 74.

FIG. 6 d illustrates that the jaw can then be closed, piercing thetissue 74 adjacent to the first passage of the suture 70 through thetissue 74. The upper pusher 86 can then be forced distally, as shown byarrow, by the handle 104. The upper pusher 86 can force or push theshuttle 14 along the track in the reverse direction from shown in FIGS.6 a and 6 b . The rear edge 24 of the suture holder 18 can then cut thetissue 74 as the suture holder 18 passes through the tissue 74, carryingthe suture 70 through the tissue 74. Thus a mattress stitch of thesuture 70 through the tissue 74 can be created.

The shuttle 14 can then be in the home position, as shown in FIG. 6 a .The upper pusher 86 can then be withdrawn from the track of the upperand/or lower jaw 80, and/or the upper pusher 86 can be left in place butthe resistive force can be removed, allowing the upper pusher 86 toslide freely in the tracks. The jaws can be reopened and repositioned,and the device 188 can create another stitch repeating the method shownin FIGS. 6 a through 6 d . The jaws can be reopened and removed from thetarget site when the stitching is complete or to deliver a secondstitch.

FIG. 7 a illustrate that the device 188 can have a base 102 and a handle104 extending from the base 102. The device 188 can have a rotatablelever 106 rotatably attached to the base 102 or handle 104. The device188 can have a compression cover 34 translatably attached to andextending distally from the base 102.

The distal end 2 of the device 188 can have the upper and lower jaws 80.The upper jaw 78 can be rotatable with respect to the lower jaw 80 andvice versa.

The compression cover 34 can be slidably attached to one or both jaws.The rotatable lever 106 can be attached to the compression cover 34. Forexample, squeezing and rotating the lever 106 toward the handle 104 canpush the compression cover distally 138 with respect to the jaws. Thecompression cover can distally slide over the jaws, rotating the upperjaw 78 toward the lower jaw 80 and closing the jaws. The lever 106 canbe spring loaded to rotate away from the handle 104, proximally retractthe compression cover 126, and return the jaws to an open configurationwhen external pressure or squeezing is no longer applied to the lever106.

FIG. 7 b illustrates that a pusher shaft or button can extend distallyfrom the base 102 or handle 104. The pusher shaft or button can betranslated with respect to the base 102 and/or handle 104, as shown byarrows. The pusher shaft can be configured to push and/or pull one orboth pushers. Pressing or pulling on the pusher shaft can translate thepusher. A single pusher shaft or button can be toggled between bothpushers.

A pusher toggle, such as a side paddle 112 can extend from the lateralside of the base 102. The side paddle 112 can be positioned on the topor bottom of the base 102 or the handle 104. The side paddle 112 canrotate 110 with respect to the base 102, as shown by arrow. The sidepaddle 112 can be configured to orient the pusher shaft or button totranslate the upper pusher 86 or lower pusher 76 depending on theposition of the side paddle 112.

The device 188 can have a lever 106 lock 120. The lever 106 lock 120 canextend laterally from the base 102. The lock 120 can rotate 118, asshown by arrows, with respect to the base 102. The lock 120 can beconfigured to fix or secure the lever 106 closed or in a particularangular position with respect to the base 102. For example, the lever106 lock can fix the lever 106 closed, in turn fixing the jaws in aclosed configuration.

FIG. 7 c illustrates that the shuttle 14 can have a rail 16 that can bea cylindrical tube or sleeve. The rail 16 can be made from Nylon, othermaterials disclosed herein, or combinations thereof. The rail 16 canhave rounded (e.g., hemi-spherical) or flat terminal longitudinal ends.

The shuttle 14 can have a suture holder 18 that can be a wire loop 98extending laterally from the rail 16. The wire loop 98 can have a wire.The wire loop 98 can extend in a flat plane. The terminal ends of thewire can be anchored - e.g., removably or fixedly attached to the rail16, for example through a port or slot in the lateral side of the rail16. The suture 70 can extend through and remain within the area definedby the perimeter of the wire loop 98 while the suture 70 is retained bythe suture 70 passer.

FIG. 7 d illustrates that the lower jaw 80 (as shown) and/or upper jaw78 can have one or more loading notches or docks 96. The loading dock 96can expose the suture holder 18, such as the wire loop 98, for suture 70loading/unloading. The suture holder 18 can extend into the loadingnotch. For example the wire loop 98 can extend through the side slot 72and into the holding notch 100 with the shuttle 14 is in a position forloading and/or unloading the suture 70 to and/or from the shuttle 14.For example, the shuttle 14 can be at the proximalmost position for theshuttle 14 on the bottom track 66 when the suture holder 18 is alignedwith the loading dock 96. The side slot 72 can terminate at the loadingdock 96, for example, interference fitting the wall of the loading dock96 against the shuttle 14 and/or suture holder 18 to prevent furthertranslation of the shuttle 14 proximally along the jaw.

The lower 80 and/or upper jaws 78 can have a septum 90 can cover amedial terminal face at the distal end 2 of the lower jaw 80 (as shown)and/or upper jaw 78. The septum 90 can be a flexible material that canbe configured to seal around all or part of the shuttle 14 as theshuttle 14 passes through the septum 90. For example, the septum 90 canbe made from a fabric, or a solid panel of polymer such as polyurethaneor polyester.

The septum 90 can have a septum rail port 92. The septum rail port 92can be aligned with the terminal end of the bottom track 66 and/or toptrack 64.

The septum 90 can have a septum slot 94. The septum slot 94 can bealigned with the side slot 72 of the bottom track 66 and/or the uppertrack 264.

The septum 90 can be configured to wipe or squeegee debris, such astissue 74 and biological fluids, from the shuttle 14 as the shuttle 14passes through the septum 90, for example to prevent or minimize debrisand fluids entering the top and/or bottom tracks 66.

FIG. 8 a illustrates that the shuttle 14 can have a rail 16 that canhave a cylinder and suture holder 18 can be as described in FIGS. 2 band 2 c . The holding notch 100 can have angular cleats 97. The holdingnotch 100 can extend to side of the rail 16.

FIG. 8 b illustrates that the shuttle 14 can be positioned so theholding notch 100 of the suture holder 18 can be in the loading dock 96when the suture 70 is attached to or removed from the holding notch 100.The suture 70 can be pressed into (e.g., for attaching) or pulled from(e.g., for removing, detaching or repositioning) the holding notch 100.A longitudinally opposing pair of first cleats 97 can laterally frictionfit or interference fit the suture 70 in the holding notch 100. Alongitudinally opposing pair of second cleats 97 can medially frictionfit or interference fit the suture 70 in the holding notch 100 (i.e.,the suture 70 can be radially fixed between the pair of first cleats 97on a lateral side of the suture 70 and the pair of second cleats 97 on amedial side of the suture 70).

The suture 70 can be radially fixed between a pair of longitudinallyopposed cleats 97 that can dig into and compress or puncture theexternal surface of the suture 70.

The shuttle 14 can interference fit or otherwise be stopped by the lowerjaw 80 from moving proximal to a position where the holding notch 100 isexposed in the loading dock 96.

FIGS. 9 a, 10 a and 10 b illustrate that the device 188 can be in anopen configuration with the upper jaw 78 positioned rotated away fromthe lower jaw 80. The upper jaw 78 can have an upper jaw longitudinalaxis. The lower jaw 80 can have a lower jaw longitudinal axis 132. Thelower jaw longitudinal axis 132 (as shown) or the upper jaw longitudinalaxis 124 can be parallel and/or collinear with the compression coverlongitudinal axis. The upper law longitudinal axis 124 and the lower jawlongitudinal axis 132 can intersect at a jaw angle 128. When the jawsare in an open configuration, the jaw angle 128 can be from about 30° toabout 45°, more narrowly from about 30° to about 40°.

The compression cover 34 can be translated and retracted proximally, asshown by arrow 126, away from the jaws. The upper jaw 78 can have a slotslide pin 130 that can extend laterally from one or both lateral sidesof the proximal end of the upper jaw 78.

The distal end 2 of the compression cover 34 can have one or more rampslots 134 on one or both lateral sides of the compression cover 34. Theramp slot 134 can narrow as the ramp slot 134 extends proximally (i.e.,widen as the ramp slot 134 extends distally). The ramp slot 134 can beat a non-zero angle (i.e., non-aligned) to the longitudinal axis of thecompression cover 34.

The slot slide pin 130 can be configured to extend through the ramp slot134. The slot slide pin 130 can slide within the ramp slot 134. The slotslide pin 130 can friction fit into the narrower, proximal end of theramp slot 134, for example friction-fitting the jaws in a closedconfiguration and providing tactile feedback to the user of the jawangle 128.

FIG. 10 a illustrates that the upper track can pass through a hinge tube149 where is extends past the distal opening of the compression cover 34and into the upper jaw. The hinge tube 149 can be made from nitinol, forexample. The hinge tube 149 can flex when the upper jaw is rotated. Thehinge tube 149 can be an integrated length of the entire upper track, orcan be a separate length of tube attached on one or each end to theremainder of the upper track.

FIGS. 9 b and 11 a illustrate that the compression cover 34 can bedistally extended or advanced, as shown by arrow 138, with respect tothe jaws. The compression cover 34 can force the jaws to rotate towardeach other to a closed configuration. For example, the upper jaw 78 canrotate, as shown by arrow 136, while the lower jaw 80 remains in arotationally fixed position with respect to the compression cover 34, orvice versa, or the jaws can both rotate with respect to the compressioncover 34. Thus, a lever, such as the trigger 8, can be actuated toadvance the outer tube or compression cover 34 to cam closed the jaws.

When the jaws are in a closed configuration, the jaw angle 128 can befrom about 0° to about 3°, more narrowly from about 0° to about 2°, forexample about 0°.

FIGS. 9 c and 11 b illustrate that the upper jaw tip 206 can be pressedinto and through the septum rail port 92. The top or upper track 264 canform a continuous lumen 152 with the bottom or lower track 148, forexample, that the shuttle 14 can slide through.

A side slot 72 of upper jaw 78 can align with a side slot 72 of lowerjaw 80. The suture holder 18 can extend through the side slot 72 andhold the suture 70 in the side slot 72. The suture holder 18 cantranslate suture 70 back and forth between the upper 78 and lower jaws80 in the side slot 72 as the shuttle 14 is translated back and forthbetween the upper 78 and lower jaws 80.

FIGS. 12 a through 12 c illustrate that the shuttle 14 can a rail 16,for example a shuttle spine 160, and shuttle 14 lateral arms or fingersextending laterally and/or inwardly from the shuttle spine 160. Theshuttle fingers 156 can extend laterally, downwardly, and medially withrespect to the shuttle spine 160, as shown. The shuttles 14 can haveslits 20 or shuttle lateral slots 158 between the shuttle fingers 156.The shuttle fingers 156 can be flexible or rigid.

The shuttle 14 can have a shuttle longitudinal axis 157. The shuttlelongitudinal axis 157 can be flat or curved, for example have a shuttleradius of curvature 154 from about 3 mm to about 5 mm, more narrowlyfrom about 3 mm to about 4 mm, for example about 3.5 mm.

The shuttle spine 160 can be flexible or rigid. The shuttle 14 can bemade from a single panel of material (e.g., metal), for example bybending and laser cutting the panel.

The suture holders 18 can be one, two or more circular, oval, orotherwise elongated, longitudinal slots in the shuttle spine 160. Forexample, the suture 70 can extend through one or both suture holders 18.The suture 70 can be fused to the shuttle 14 adjacent to the sutureholders 18. A detachable or fixed frame can be attached to the slots inthe shuttle 14 and the suture 70 can be attached to the detachableframe. For example, the detachable frame can be an arc-shaped wireattached at a first end to a first slot in the shuttle spine 160 and ata second end to the adjacent second slot in the shuttle spine 160.

FIG. 13 a illustrates that the suture holder 18 can be an arc integralwith the shuttle spine 160. For example, the shuttle 14 can be made froma single panel of material (e.g., metal). The lateral sides of thesuture holder 18 can be cut, and the longitudinal ends can remainintegrated with the shuttle spine 160. The suture holder 18 can then bebent or otherwise deformed away from the plane of the shuttle spine 160,for example forming an arc away from the plane of the shuttle spine 160.

The suture 70 can have a suture loop 162 at the terminal end of thesuture 70. The suture loop 162 can extend around and completely orpartially circumscribe the suture holder 18. The remainder of the suture70 can be integral with the suture loop 162, or can removably attachedto the suture loop 162. The suture loop 162 can be circular or oval.

FIG. 13 b illustrates that the shuttle 14 can have one or more shuttlenotches 166 or cut-outs. For example, the shuttle 14 can have twoshuttle notches 166 on each lateral site of the shuttle. The shuttlenotches 166 can be even longitudinally spaced and distributed along theshuttle 14. The shuttle notches 166 can be curved. The sides of theshuttle 14, other than at the notches, can be straight.

A radius of curvature of the shuttle notch 166 can be from about 1 mm toabout 2 mm.

FIGS. 14 a through 14 c illustrate that one or both of thelongitudinally terminal ends of the shuttle 14 can be curved orsharpened shuttle tips 164. For example, the shuttle tip 164 can have anangled chisel tip or needle tip.

The shuttle holder can have a holder leader 170 extending away from theshuttle spine 160. The end of the holder leader 170 away from theshuttle spine 160 can be a closed wire loop 98 configured to attach tothe suture 70. A loop neck 172, such as a dual clamp, can fix a firstterminal end of the leader wire to an intermediate point on the holderleader 170, as shown. A second terminal end of the holder leader 170 canextend through the shuttle longitudinal slot 174 and terminate at aleader anchor 168 such as a crimp or swaged ball or disc having a largerdiameter than the width of the shuttle longitudinal slot 174, forexample to slidably attach the suture holder 18 to the shuttlelongitudinal slot 174. The suture holder 18 can be slidably captured inthe shuttle longitudinal slot 174 by the leader anchor 168.

The holder leader 170 can be translatably and/or rotationally fixed inthe shuttle longitudinal slot 174 or can slide and/or rotate in theshuttle longitudinal slot 174. For example, the wire loop 98 can extendpast a first end of the shuttle spine 160 when the shuttle 14 is beingtranslated in a first direction (e.g., toward the lower jaw 80 from theupper jaw 78), and the holder leader 170 can passively rotate andtranslate when the shuttle 14 is then translated in a second direction(e.g., toward the upper jaw 78 from the lower jaw 80).

The holder leader 170 can be rigid or flexible. For example, the holderleader 170 can be made from stainless steel, other material disclosedherein, or combinations thereof.

The suture 70 can be passed through and/or tied to the wire loop 98. Thewire loop 98 can be at a height away from the shuttle spine 160. Thewire loop 98 can extend proximally or distally past the end of theshuttle tip 164. For example, the suture 70 can be attached to the wireloop 98 away from sharp edge sharps to minimize the risk of cutting ordamaging the suture 70.

FIGS. 15 a and 15 b illustrate that suture 70 can be directly attachedor fused to the shuttle spine 160 at a suture attachment 176 in thelongitudinal and lateral middle of the shuttle 14. The suture 70 can bebraided.

For example, the entire shuttle 14 can be made from plastic and can bemolded, overmolded, or otherwise joined to a plastic suture. The suturecan be thermally formed to the shuttle 14. The suture 70 can extendthrough the shuttle 14, for example at a suture anchor 178. The sutureanchor 178 can be the terminal end of the suture 70 extending throughand attached to the shuttle 14.

FIGS. 16 a and 16 b illustrate that the leader or wire loop 98 canextend partially or entirely in a plane perpendicular to the plane ofthe shuttle spine 160. A first terminal end of the wire loop 98 can havea leader first anchor 184. A second terminal end of the wire loop 98 canhave a leader second anchor 186. The shuttle spine 160 can have ashuttle longitudinal first slot 180 and a shuttle longitudinal secondslot 182. The shuttle longitudinal slots 174 can be elongated orcircular. The wire loop 98 can be made from Nitinol and/or steel, forexample, and can be tied to the suture.

The wire loop 98 can extend through the shuttle longitudinal slots 174.The leader first and second anchors can be on the underside (e.g., theconcave side or radially interior side) of the shuttle spine 160. Thewire loop 98 can be on the outerside (e.g., the convex side or radiallyexterior side) of the shuttle spine 160. Neither, one, or both of theleader anchors 168 can be fixed or integrated (e.g., melted or welded)to the shuttle spine 160. Neither, one or both of the leader anchors 168can be slidably attached to the longitudinal slots. The wire loop 98 canbe fixed or slide longitudinally with respect to the shuttle spine 160.

The wire loop 98 can have a longitudinally symmetric or assymetric (asshown) shape. For example, the wire loop 98 can be an arc (similar tothe shape shown by the suture holder 18 in FIGS. 13 a and 13 b ) or canassymetrically overhang (as shown) toward one of the ends of thelongitudinal shuttle.

FIG. 17 a illustrates that the device 188 can have the shuttle 14 in aposition spanning across the upper jaw 78 and the lower jaw 80. The jawscan have jaw lateral ridges 190. The shuttle fingers 156 can wrap aroundthe jaw lateral ridges 190, for example, slidably attaching the shuttleto the jaws. The jaw lateral ridges 190 at the terminal ends of theupper 78 or top jaw 30 and the bottom or lower jaw 80 can align when thejaws are in a closed configuration, for example so the shuttle 14 canslide along a continuous ridge between the upper 78 and lower jaws 80.

FIG. 17 b illustrates that the device 188 can have a lower pusher 76slidably attached to the jaw lateral ridge 190 on the lower jaw 80. Thelower pusher 76 can abut the shuttle 14.

FIG. 17 c illustrates that the device 188 can have an upper pusher 86slidably attached to the jaw lateral ridge 190 on the upper jaw 78. Theupper 86 and/or lower pushers 76 can be shaped like the shuttle 14. Theshuttle 14 can be pushed onto a straight length of the lower jaw 80. Theshuttle 14 can deform to a straight configuration when on a straightlength of the jaws and to a curved configuration when on a curved lengthof the jaws.

The pushers can be generally shaped similarly to the shuttles 14, havingfingers, longitudinal slots, spines and lateral slots between thefingers. More than one pusher can be used concurrently on a singledevice 188 (e.g., if the pushers in FIGS. 17 b through 17 d wereshuttles 14 and if additional pushers were used), for example to delivermultiple sutures 70 to the same target site.

FIG. 17 d illustrates that the shuttle 14 can be pushed, as shown, tothe upper jaw 78 by the lower pusher 76. The lower pusher 76 can thenretreat onto the lower jaw 80.

FIGS. 18 a and 18 b illustrate that the upper and/or lower jaws 80 caneach have jaw spines 208. The jaw spines 208 can extend medially fromthe remainder of the jaws toward (as shown) or away from the jaw controlextension longitudinal axis. For example, the jaws spines can extendfrom the remainder of the jaws distally until the terminal distal ends 2of the jaws, distal to where the jaws extend into a medially-curved jawmedial extension closer to and in the respective jaw tip from a jawlongitudinal extension 191, 202.

The jaws can have jaw lateral ridges 190 or rails 16, as describedelsewhere herein. The jaws can have a T-shaped cross-section.

The shuttle 14 can have shuttle fingers 156 that can each have a shuttledownward extension 196. The shuttle finger 156 can each have a shuttlelateral extensions 192 extending laterally from the respective shuttlespine 160. The shuttle fingers 156 can have shuttle downward extensions196 that can each extend downward (e.g., toward the longitudinal axis ofthe jaw structure) from the laterally terminal ends of the lateralextensions. The shuttle fingers 156 can have shuttle inward extensions194 that can extend inward from the shuttle downward extensions 196. Theshuttle spines 160 and/or lateral extensions, downward extensions, andinward extensions can slidably wrap around the jaw lateral ridges 190.

The upper jaw tip 206 and/or lower jaw tip 198 can have blunt, beveled(e.g., needle-tip), chisel (e.g., beveled on opposite sides, as shown inFIGS. 18 a and 18 b ), conical, Sprotte, diamond, Tuohy tips, orcombinations thereof (e.g., the upper jaw tip 206 can have a first tipshape and the lower jaw tip 198 can have a second tip shape). The bevelon the distal side of the jaw tips can have the same angle and length,or a smaller angle and longer length than the bevel on the proximal sideof the jaw tips.

The upper jaw tip 206 can have a tip gap 290 or touch the lower jaw tip198 when the jaws are in a closed configuration.

FIGS. 19 a and 19 b illustrate that the jaw spines 208 in one or bothjaws can terminate before the respective jaw tips or jaw medialextensions.

The bevel on the proximal side of the jaw tips can have a smaller angleand longer length than the bevel on the distal side of the jaw tips.

FIGS. 20 a and 20 b illustrate that the jaw spine 208 on the upper jaw78 can extend along the straight length of the upper jaw 78 and canterminate at or proximal to the upper jaw medial extension 204 or upperjaw tip 206. The jaw lateral ridge 190 on the upper jaw 78 can extend tothe terminal distal tip of the upper jaw 78.

The jaw spine 208 on the lower jaw 80 can extend to the terminal distaltip of the lower jaw 80.

The jaw lateral ridge 190 on the lower jaw 80 can extend along thestraight length of the lower jaw 80 and can terminate at or proximal tothe lower jaw medial extension 200 or lower jaw tip 198.

When the jaws are in a closed configuration, the lower jaw tip 198 canbe positioned proximally to and overlap the upper jaw tip 206. The upperjaw tip 206 and lower jaw tip 198 can overlap along a tip interface 211.For example, the distal end 2 of the jaw spine 208 on the lower jaw 80can overlap and slide against the proximal side of the upper jaw tip206. The upper jaw tip 206 can contact the lower jaw tip 198 at the tipinterface 211 or there can be a gap between the upper jaw tip 206 andthe lower jaw tip 198 at the tip interface 211.

The tip interface 211 can have a tip interface axis 214 with respect tothe jaw structure longitudinal axis 42. The tip interface axis 214 canintersect the jaw structure longitudinal axis 42 at a tip interfaceangle 212 of about 90°.

The upper jaw tip 206 can be distal to the lower jaw tip 198 at the tipinterface 211.

The distal terminal end of the jaw lateral ridge 190 of the upper jaw 78can contact or not contact the distal terminal end of the jaw lateralridge 190 of the lower jaw 80 when the jaws are in a closedconfiguration.

FIGS. 21 a and 21 b illustrate that the tip interface 211 can have a tipinterface axis 214 with respect to the jaw structure longitudinal axis42. The lower jaw tip 198 can be distal to the upper jaw tip 206 at thetip interface 211. The tip interface angle 212 can be from about 30° toabout 60°, more narrowly 30° to about 45°, for example about 35°.

FIGS. 22 a through 22 c illustrate that the distal end 2 of the lowerjaw tip 198 (as shown) or upper jaw tip 206 can have a tip seat 216. Thetip seat 216 can be shaped to receive the shape of the opposite jaw tip.For example, the tip seat 216 can be triangular (e.g., A-shaped orV-shaped).

The tip seat 216 can surround the lateral sides and distal side of theupper jaw tip 206 when the jaws are in a closed configuration. The tipseat 216 can contact or not contact (i.e., there can be a gap) the upperjaw tip 206 when the jaws are in a closed configuration.

The jaw lateral ridge 190 of the jaw with the tip seat 216 (the bottomjaw 38, as shown) can extend to the terminal end of the lower jaw tip198 and the tip seat 216. The jaw lateral ridge 190 of the jaw oppositeof the tip seat 216 (the upper jaw 78, as shown) can narrow, for to apoint at the terminal end of the respective jaw tip. The narrowed jawlateral ridge 190 can be received within the tip seat 216.

FIGS. 23 a and 23 b illustrate that the upper 78 and/or lower jaws 80can have circular or oval cross-sections. The upper 78 and/or lower jaws80 can be made from solid or hollow rods, for example having a diameterof from about 0.030 in. to about 0.100 in., for example about 0.060 in.

The terminal end of the upper and/or lower jaw tip 198 can have aconical shape. The terminal end of the lower jaw tip 198 can have an tipseat 216 that can be inverse or negative to a conical shape, for examplesized and shaped to receive the upper jaw tip 206.

The shuttle 14 can have a circular or oval cross-section.

The pushers can have pusher fingers 219 extending from the pusher spine218, similar to the shuttle fingers 156 and shuttle spine 160. Thepusher fingers 219 can be triangular.

FIGS. 24 a through 24 c illustrate that the distal end 2 of the device188 can be inserted into a cannula 226, for example to be deployedpercutaneously through a cannula 226 inserted in a patient at a targetsite. The cannula 226 can have a cannula inner diameter 228. The cannulainner diameter 228 can be from about 4 mm to about 8 mm, for example 7mm, or 6.86 mm (0.270 in.), or 15 French gauge (5 mm (0.197 in.)).

The shuttle 14 can have a shuttle height 220. The shuttle height 220 canbe from about 0.020 in. to 0.060 in., for example about 0.041 in.

The compression cover 34 can be attached to or integral with one or morejaw control extensions 40. For example the jaw control extensions 40 canextend from the lateral distal ends 2 of the compression cover 34. Thejaw control extension 40 can slidably attach to or contact the jawsdirectly or indirectly. The jaw control extension 40 can push the jawsapart from each other when the jaw control extension 40 is translatedproximally with respect to the jaws, and toward each other when the jawcontrol extension 40 is translated distally with respect to the jaws.

One or more upper cam pins 222 can extend laterally from the one or bothlateral sides of the proximal end of the upper jaw 78. One or more lowercam pins 232 can extend laterally from the one or both lateral sides ofthe proximal end of the lower jaw 80 at the same or differentlongitudinal position as the upper cam pins 222.

The jaw control extensions 40 can have one or more upper cam slots 230and one or more lower cam slots 224. The upper 230 and/or lower camslots 224 can be straight, curved, angled (as shown) or a combinationthereof. The cam pins can be positioned inside and through therespective cam slots. The cam pins can slide within the cam slots.

When the jaw control extension 40 is translated distally with respect tothe jaws, the cam pins can slide proximally within the respective camslots and rotate the jaws away from each other. When the jaw controlextension 40 is translated proximally with respect to the jaws, the campins can slide distally within the cam slots and rotate the jaws towardeach other.

The jaws can have a jaw extension length 234. The jaw extension length234 can be the length from the distal end 2 of the jaw control extension40 to the proximal side of the jaw tips. The jaw extension length 234when the jaws are in a closed configuration can be from about 5 mm toabout 30 mm, for example about 16 mm and 15.95 mm.

The jaws can have a jaw straight gap 236 along the straight length ofthe jaws. The jaw straight gap 236 can be from about 1 mm to about 3.5mm, for example about 1.1 mm or about 3.2 mm. For example, the cannulainner diameter 228 can be 5 mm and the jaw straight gap 236 can be about1.1 mm.

The jaws can be separate or can be integrated at a jaw body. Jawsintegrated in a jaw body can rotatably deform away from each other whenmoved into an open configuration.

FIGS. 25 a through 25 f illustrate that the upper jaw tip 206 and/orlower jaw tip 198 can have suture holder slots 238. The suture holderslots 238 can extend medially along the outer surface of the respectivejaw tip. The suture holder slot 238 can extend from the outer surface ofthe jaw tip to the respective track. The suture holder 18 can beaccessible through or extend out of the suture holder slot 238. Thesuture 70 (not shown) can attach to or be integral with the sutureholder 18 in or outside of the suture holder slot 238.

The upper track 264 can distally terminate at an upper jaw tip shuttleport 240. The lower track 148 can distally terminate at a lower jaw tipshuttle port 256. The shuttle 14 can extend out of or into, and passthrough each of the shuttle 14 ports. During use, the sharpened shuttletip 164 extending out of the shuttle port can pierce, cut and dissecttissue 74 when the jaws are rotated to a closed configuration.

The upper jaw 78 and/or lower jaw 80 can have a jaw stop 242. The jawstop 242 can be a feature, shape or configuration that can abut and stopthe distal translation of the compression cover 34 with respect to thejaws. For example, the distal terminal end of the compression cover 34can abut the jaw stops 242 when the jaws are in a closed configuration.

The radially inner surface of the jaws can have radially inner slopes250.

The upper jaw 78 and/or lower jaw 80 can have a jaw slide 244. The jawslide 244 can be a radially outer surface of the jaws between the jawstops 242 and the compression cover 34 when the compression cover 34 isin a proximally retracted 126 position with respect to the jaws and/orthe jaws are in an opened configuration. The jaw slide 244 can increasein radius from the jaw structure longitudinal axis 42 in the distallongitudinal direction (e.g., the larger the longitudinal dimension ofthe jaw slide 244, the larger the radial dimension of the jaw slide244). When the compression cover is translated distally 138 with respectto the jaws, the radially inner distal edge of the compression cover 34can slide along the jaw slide 244, and press the jaw slide 244 towardthe jaw structure longitudinal axis 42. A radially compressive forcedelivered from the compression cover 34 to the jaw slide 244 can createa torque in the respective jaw, rotating the respective jaw toward thejaw structure longitudinal axis 42 and the opposing jaw.

The device 188 can have a jaw control extension 40. The jaw controlextension 40 can extend along the jaw structure longitudinal axis 42.The jaw control extension 40 can extend between the jaws proximal to thejaw tips. The jaw control extensions 40 can terminate in a jaw controlextension head 254.

The jaw control extension head 254 can have one or two lobes or cams.Each lobe can extend from the longitudinal axis of the jaw controlextension 40 toward a jaw. The lobes can act similarly to the openingroller ball shown in FIGS. 4 a, 4 d , and elsewhere herein. The upperjaw 78 and lower jaw 80 can have upper and inner jaw radially innerslopes 250, respectively. The inner slopes can be the radially innersurfaces of the jaws proximal to the jaw tips and distal to the jawcontrol extension head 254 when the jaw control extension head 254 is ina proximally retracted position with respect to the jaws. The radiallyinner slope 250 can increase in radius from the jaw structurelongitudinal axis 42 in the distal longitudinal direction (e.g., thelarger the longitudinal dimension of the radially inner slope 250, thelarger the radial dimension of the radially inner slope 250). When thejaw control extension 40 is proximally translated or retracted withrespect to the jaws, the lobes can slide against the radially innerslopes 250 of the jaws and press the jaws away from each other into anopen configuration.

When the jaws are in an open configuration, the compression cover 34 canbe positioned at or proximally past the proximal end of the jaw slides244, and the jaw extension head can be positioned at or proximally pastthe proximal end of the radially inner slopes 250.

The jaw control extension 40 can be attached to or integral with acontrol rail 248. The control rail 248 can extend radially from one orboth lateral sides of the jaw control extension 40, for example in aplane at a right angle to a plane defined by the opposing jaws or theopposing extension head lobes 252.

The compression cover 34 can have a control rail slot 246. The controlrail slot 246 can extend to the distal terminal end of the compressioncover 34. The control rail 248 can be fixed to or longitudinallytranslate within the control rail slot 246. The control rail 248 caninterference fit, abut or stop against the proximal end of the controlrail slot 246, for example when the control rail 248 is in a proximal ordistal longitudinal position with respect to the jaws. The control rail248 can move longitudinally in unison (i.e., coincidentally) with thecompression cover 34 in the distal and/or longitudinal directions. Thecontrol rail 248 can move longitudinally in unison with the jaw controlextension 40 in the distal and/or longitudinal directions.

The device 188 can have an upper socket arm 258 and a lower socket arm270 radially inside of the compression cover 34. The upper socket arm258 and lower socket arm 270 can be a single integrated element (e.g., ahollow cylinder) or separate elements. The upper socket arm 258 can beopposite the lower socket arm 270. The upper socket arm 258 can betranslatably fixed (i.e., mechanically attached to translate in unison)to the lower socket arm 270. The jaw control extension 40 can extendlongitudinally between the upper 258 and lower socket arms 270 or withina hollow channel inside a unitary socket arm (comprising the upper 258and lower socket arms 270 as an integrated element). The distal terminalends of the socket arms can extend to or proximal to the distal terminalend of the compression cover 34 when the jaws are in an openconfiguration.

The proximal terminal end of the upper jaw 78 can have a laterallyelongated upper jaw bearing 262. The upper jaw bearing 262 can extendradially outward from the remainder for the proximal end of the upperjaw 78.

The distal end 2 of the upper socket arm 258 can have a laterallyelongated upper jaw socket 260. The upper jaw socket 260 can openmedially and have a diameter approximately equal to or slightly largerthan the diameter of the upper jaw bearing 262.

An upper jaw 78 hinge can have the upper jaw bearing 262 and the upperjaw socket 260. The upper jaw 78 can rotate around the transverse axisof the upper jaw bearing 262. The upper jaw bearing 262 can rotate inthe upper jaw socket 260.

The proximal terminal end of the lower jaw 80 can have a laterallyelongated lower jaw bearing 266. The lower jaw bearing 266 can extendradially outward from the remainder for the proximal end of the lowerjaw 80.

The distal end 2 of the lower socket arm 270 can have a laterallyelongated lower jaw socket 268. The lower jaw socket 268 can openmedially and have a diameter approximately equal to or slightly largerthan the diameter of the lower jaw bearing 266.

A lower jaw 80 hinge can have the lower jaw bearing 266 and the lowerjaw socket 268. The lower jaw 80 can rotate around the transverse axisof the lower jaw bearing 266. The lower jaw bearing 266 can rotate inthe lower jaw socket 268.

The upper 86 and/or lower pushers 76 can have entire lengths or onlydistal ends 2 that can have articulated segmentations 286. Thearticulated segments 286 can rotate with respect to each other around anaxis perpendicular to the longitudinal axis of the respective pusher.The articulated segmentations 286 can be connected by a discrete hinge(e.g., a pin or snap connection) or can be longitudinally coincidentalor longitudinally alternating lateral slots cut into the sides of thepusher, similar to the shape of the shuttle lateral slots 158. Theproximal end of either or both upper 86 and lower pushers 76 can have acontinuous, non-segmented, flat, uniform ribbon of material.

Each of the upper 86 and/or lower pushers 76 can have distal terminalends that can have a shuttle seat 274. The shuttle seat 274 can be aninverse shape to the shape of the shuttle tip 164. For example, if theshuttle tip 164 has an angled end, the shuttle seat 274 can have theopposite angle. If the shuttle tip 164 has a convex curved end, theshuttle seat 274 can have a concave curved end with the same radius ofcurvature as the shuttle tip 164.

FIGS. 26 a through 26 d illustrate that the compression cover 34 can bedistally translated, as shown by arrow, with respect to the jaws. Thecompression cover 34 can deliver translational force through the edgesof the control rail slot 246 to the control rail 248. The control rail248 can deliver the translational force to the jaw control extension 40.The jaw control extension 40 can translate distally, as shown by arrow,concurrently with the compression cover 34. The compression cover 34 cantranslate 138 over the jaw slides 244, pressing radially inward on thejaw slides 244. The jaw control extension head 254 can move distallywith respect to the jaws, as shown by arrow 280, for example, allowingthe closure of the jaws without interference fitting or abutting againstthe jaw control extension head 254. The upper jaw 78 and/or lower jaw 80can rotate radially inward, as shown by arrows.

When the jaws are in a closed configuration, the compression cover 34can be positioned at or adjacent to the jaw stop 242, and the jawextension head can be positioned at or proximally past the proximal endof the radially inner slopes 250.

When the jaws are in a closed configuration, if the shuttle 14 is in theupper track 264, the upper pusher 86 can translate distally through theupper track 264. The distal terminal end of the upper pusher 86 can abutthe shuttle 14. The upper pusher 86 can then push the shuttle 14 throughthe upper track 264, out the upper jaw tip shuttle port 240 and into thelower jaw tip shuttle port 256.

When the jaws are in a closed configuration, if the shuttle 14 is in thelower track 148, the lower pusher 76 can translate distally through thelower track 148. The distal terminal end of the lower pusher 76 can abutthe shuttle 14. The lower pusher 76 can then push the shuttle 14 throughthe lower track 148, out the lower jaw tip shuttle port 256 and into theupper jaw tip shuttle port 240.

When the shuttle 14 is pushed from the upper track 264 to the lowertrack 148 or vice versa, the shuttle 14 can be curvilinearly translated282, as shown by arrow, following the paths of the upper track 264 andthe lower track 148.

When the jaws are in a closed configuration, the shuttle 14 can movefrom the upper jaw 78 to the lower jaw 80, as shown by arrow, back tothe upper jaw 78, and can repeat the motion from the upper jaw 78 to thelower jaw 80, and optionally from the lower jaw 80 to the upper jaw 78one, two or more times.

The device 188 can have a pusher lockout that can prevent translation ofthe pushers and the shuttle 14 when the jaws are in an openconfiguration.

The device 188 can have a jaw lockout preventing opening of the jawswhen either of the pushers is extended out of the respective jaw tipshuttle port and/or when the shuttle 14 is concurrently in the upper jaw78 and the lower jaw 80.

FIG. 27 illustrates that the upper pusher 86 can be distally translatedwith respect to the jaws. The upper pusher 86 can curvilenearlytranslate, as shown by arrows 284 and 288, along the upper track 264.The distal terminal end of the upper pusher 86 can exit out of andextend from the upper jaw tip shuttle port 240. The V-shaped (orA-shaped), or curved (e.g., U-shaped) shuttle seat 274 at the distalterminal end of the upper pusher 86 can abut the V-shaped (or A-shaped),or curved (e.g., U-shaped) shuttle tip 164 at the terminal end of theshuttle. The upper pusher 86 can push the shuttle 14 through the uppertrack 264, across the gap between the upper jaw tip shuttle port 240 andthe lower jaw tip shuttle port 256, and into the lower track 148. Theshuttle 14 can have a curvilinear translation 282, as shown by arrow,along the tracks.

The lower pusher 76 can have no or one lower pusher articulating segment(as shown), or can have a number of articulating segments, similar tothe upper pusher 86 in FIG. 27 .

FIG. 28 illustrates that the suture 70 can be tied or adhered directlyto suture holder 18, for example as shown in FIGS. 13 a and 13 b . Thesuture 70 can have a suture loop 162. The suture loop 162 cancircumscribe the suture holder 18.

FIG. 29 illustrates that when the jaws are in a closed configuration,the terminal end of the upper jaw tip 206 can be in contact with or havea tip gap 290 to the terminal end of the lower tip jaw. The tip gap 290can be from about 0 in. to about 0.020 in., for example about 0.008 in.

The shuttle 14 can have a shuttle width 292. The shuttle width 292 canbe from about 0.030 in. to about 0.100 in., for example about 0.060 in.

The shuttle 14 can be made from nickel titanium alloys (e.g., Nitinol),stainless steel, other materials disclosed herein, or combinationsthereof.

FIGS. 30 a, 30 b and 31 illustrate that the lever 106 or handle 104 cancontrol the rotation, and opening and closing of the jaws.

The handle 104 can have a handle pivot 302. The handle pivot 302 can bea rotatable pin joint where the handle 104 can rotatably attach to thebase 102. The handle 104 can rotate around the handle pivot 302 withrespect to the base 102.

The handle 104 can be attached to the socket arms and/or the compressioncover 34 (as shown). For example, the compression cover 34 can haveradially and/or laterally extending cover pins 304. The cover pins 304can attach to the jaw control extension 40. The handle 104 can have oneor two transmission ports 314 or loops 296 on opposing lateral sides ofthe compression cover 34. The cover pins 304 can extend through thetransmission loops 296.

The other of the socket arms (as shown) and compression cover 34 notattached to the handle 104 can be attached to the base 102.

Squeezing and rotating the handle 104 toward the base 102 can distallyextend 138 the compression cover 34 and jaw control extension 40 withrespect to the jaws, or proximally retract 126 the jaws with respect tothe compression cover 34 and jaw control extension 40. When the handle104 is rotated, the jaws can move to an open configuration. For example,when the bottom of the handle 104 is rotated proximally toward the base102, the transmission loop 296 can rotate distally toward the jaws,pushing the cover pin 304 and the compression cover 34 distally. Thetransmission loop 296 can force the compression cover 34 and/or jawcontrol extension 40 to translate distally, for example, closing thejaws.

The proximal end of the upper socket arm 258 and the proximal end of thelower socket arm 270 can be an integral element or can be fixedlyattached by a socket arm brace 300.

The terminal proximal end of the upper pusher 86 can attach to or beintegrated with an upper pusher 86 shaft and/or upper pusher button 210a. The terminal proximal end of the lower pusher 76 can attach to or beintegrated with a lower pusher shaft and/or lower pusher button 210 b.The proximal distal ends 2 of the upper pusher button 210 a and lowerpusher button 210 b can be above and below each other or side-by-side(e.g., left and right, as shown). The device 188 can be configured sothat pressing (e.g., distally translating) the upper pusher button 210 acan distally advance the upper pusher 86, and pressing (e.g., distallytranslating) the lower pusher button 210 b can distally advance theupper pusher 86. Pressing the upper pusher button 210 can proximallyretract the lower pusher 76 and/or lower pusher button 210 b. Pressingthe lower pusher button 210 b can proximally retract the upper pusher 86and/or upper pusher button 210.

The medial sides of the distal ends 2 of the upper and lower pusherbuttons 210 b can have upper pusher button gears 310 and lower pusherbutton gears 306, respectively. The upper pusher button gears 310 canface the lower pusher button gears 306.

The pusher toggle knob 294 can be rotatably attached to the base 102.The pusher toggle knob 294 can be integrated or rotationally fixed to apusher toggle knob gear 308. The pusher toggle knob gear 308 canrotatably interface and interdigitate with the upper pusher button gear310 on a first side and with the lower pusher button gear 306 on theopposite side of the upper pusher button gear 310.

When the upper pusher button translates distally 284, the upper pusherbutton gear 310 can rotate the pusher toggle gear, for example alsorotating the top of the pusher toggle knob 294 to a position indicatingthat the upper pusher button 210 a has been translated distally 284. Thetop surface or circumference of the top of the pusher toggle knob 294can have an indicator, such as an arrow, that can indicate whether theupper pusher 86 or the lower pusher 76 has been translated and by howfar, for example indicating the position of the shuttle 14 in the uppertrack 264, lower track 148, extending out of one track, or extendingacross both tracks simultaneously. The pusher toggle gear cansimultaneously proximally translate the lower pusher button gear 306.For example, when the upper pusher 86 is distally translated, the lowerpusher 76 can be simultaneously proximally translated at the same speed.

When the lower pusher button 210 b translates distally, the lower pusherbutton gear 306 can rotate the pusher toggle gear, for example alsorotating the top of the pusher toggle knob 294 to a position indicatingthat the upper pusher button 210 a has been translated distally 284. Thepusher toggle gear can simultaneously proximally translate the upperpusher button gear 310. For example, when the lower pusher 76 isdistally translated, the upper pusher 86 can be simultaneouslyproximally translated at the same speed.

The pusher toggle knob 294 can be rotated to translate the upper pusher86 and the lower pusher 76 by transmitting the torque applied to pushertoggle knob 294 through the pusher toggle knob gear 308 and to the upperpusher button gear 310 and/or lower pusher button gear 306 with orwithout pressing on the proximal terminal ends of the pusher buttons.

FIGS. 32 a and 32 b illustrates that the the pusher toggle knob 294 canbe rotated to translate the upper pusher 86 and the lower pusher 76 bytransmitting the torque applied to pusher toggle knob 294 through thepusher toggle knob gear 308 and to the upper pusher button gear 310and/or lower pusher button gear 306 with or without pressing on theproximal terminal ends of the pusher buttons.

The diameter of the pusher toggle knob 294 can be smaller than the widthof the base 102, as shown in FIGS. 30 a, 30 b and 31 , or larger thanthe width and height of the base 102, and the same size or larger thanthe handle 104, and the compression cover 34, as shown in FIGS. 32 a and32 b .

In a variation of a method of use, the distal end 2 of the device 188including the jaws can be inserted through a percutaneous cannula 226when the jaws are in a closed configuration. When the distal end 2 ofthe device 188 exits the distal end 2 of the cannula 226 at the targetsite, the handle 104 can be released to rotate away from the base 102.The handle rotation away from the base 102 can move the jaws to an openconfiguration. The distal end 2 of the device 188 can then be furtherpositioned so the target site is between the upper jaw distal tip 206and the lower jaw distal tip 198. The handle 104 can then be squeezed torotate the handle 104 toward the base 102. The handle rotation towardthe base 102 can move the jaws into a closed configuration, pinchingtogether tissue 74 at the target site. The shuttle 14 can be completelyrecessed in the jaw into which the shuttle 14 is loaded, or the shuttletip 164 can extend out of whichever jaw the shuttle is currently loadedinto. The shuttle tip 164 can pierce the tissue 74 as the jaws areclosed or after the jaws are closed when the shuttle 14 is translated.

After the jaws are closed, the upper 210 a or lower pusher button 210 b(e.g., respective to whichever track the shuttle 14 is currently in) canbe pressed, distally advancing the respective pusher. The respectivepusher can press the shuttle 14 distally, through the gap between theupper 78 and lower jaws 80, if such a gap exists, or directly from onejaw to the other jaw. The shuttle 14 can pull the suture 70 to followthe path of the shuttle 14 or follow a path adjacent to the shuttle 14.When the respective pusher button is fully depressed, the device 188 canemit a sound and/or tactile response (e.g., from a snap or detent in thebutton or pusher and track) and the pusher toggle knob 294 can have anindicator (e.g., a line or arrow) indicating that the shuttle 14 hasbeen fully translated across the jaws.

The handle 104 can then be rotated away from the base 102. For example,the handle 104 can be released and spring loaded to return to a positionrotated away from the base 102. The rotating handle can proximallytranslate the transmission loop 296. The transmission loop 296 canproximally pull and translate the compression cover 34 and jaw controlextension 40, opening the jaws.

The device 188 can then be repositioned so the jaw tips are removedentirely, for example if stitching is complete, or moved adjacent totheir previous position in order to place a new stitch. The handle 104can then be squeezed, closing the jaws. The pusher button of the trackin which the shuttle 14 is positioned can then be pressed. The shuttle14 can then move to the opposite jaw, as described above, pulling thesuture 70 through the tissue 74 and forming a stitch.

The above method can be repeated as needed to create a length andposition of desired stitches.

Any or all elements of the device 188 and/or other devices 188 orapparatuses described herein can be made from, for example, a single ormultiple stainless steel alloys, nickel titanium alloys (e.g., Nitinol),cobalt-chrome alloys (e.g., ELGILOY® from Elgin Specialty Metals, Elgin,IL; CONICHROME® from Carpenter Metals Corp., Wyomissing, PA),nickel-cobalt alloys (e.g., MP35N® from Magellan Industrial TradingCompany, Inc., Westport, CT), molybdenum alloys (e.g., molybdenum TZMalloy, for example), tungsten-rhenium alloys, polymers such aspolyethylene teraphathalate (PET)/polyester (e.g., DACRON® from E. I. DuPont de Nemours and Company, Wilmington, DE), polypropylene, (PET),polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyether ketone(PEK), polyether ether ketone (PEEK), poly ether ketone ketone (PEKK)(also poly aryl ether ketone ketone), nylon, polyether-blockco-polyamide polymers (e.g., PEBAX® from ATOFINA, Paris, France),aliphatic polyether polyurethanes (e.g., TECOFLEX® from ThermedicsPolymer Products, Wilmington, MA), polyvinyl chloride (PVC),polyurethane, thermoplastic, fluorinated ethylene propylene (FEP),absorbable or resorbable polymers such as polyglycolic acid (PGA),polylactic acid (PLA), polycaprolactone (PCL), polyethyl acrylate (PEA),polydioxanone (PDS), and pseudo-polyamino tyrosine-based acids, extrudedcollagen, silicone, zinc, echogenic, radioactive, radiopaque materials,a biomaterial (e.g., cadaver tissue 74, collagen, allograft, autograft,xenograft, bone cement, morselized bone, osteogenic powder, beads ofbone) any of the other materials listed herein or combinations thereof.Examples of radiopaque materials are barium sulfate, zinc oxide,titanium, stainless steel, nickel-titanium alloys, tantalum and gold.

The shuttle 14 throughout the disclosure herein can be attached to asuture 70. Accordingly, the suture 70 can be attached to the shuttle 14and can follow the movement of the shuttle 14. Similarly, the suture 70can be attached to and detached from the shuttle 14, for example,attached before and detached after the desired stitching or suturing iscomplete.

It is apparent to one skilled in the art that various changes andmodifications can be made to this disclosure, and equivalents employed,without departing from the spirit and scope of the invention. Elementsshown with any variation are exemplary for the specific variation andcan be used on other variations within this disclosure. Any elementsdescribed herein as singular can be pluralized (i.e., anything describedas “one” can be more than one). Any species element of a genus elementcan have the characteristics or elements of any other species element ofthat genus. The above-described configurations, elements or completeassemblies and methods and their elements for carrying out theinvention, and variations of aspects of the invention can be combinedand modified with each other in any combination.

We claim:
 1. A system disclosed herein.
 2. A device disclosed herein. 3.A method disclosed herein.